Ax-003/Arimidex (Anastrozole) in the Adjuvant Therapy of... | NCT00638391

Studies
Ax-003/Arimidex (Anastrozole) in the Adjuvant Therapy of Early Breast Cancer

NCT00638391

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Mar 20, 2008Estimated

Enrollment

1,600Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

Anastrozole

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Ax-003/Arimidex

Status Module

Record Verification Date

Mar 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2005

Primary Completion Date

Not provided

Completion Date

Mar 2007Actual

First Submitted Date

Mar 13, 2008

First Submission Date that Met QC Criteria

Mar 18, 2008

First Posted Date

Mar 19, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2008

Last Update Posted Date

Mar 20, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,600Actual

Label	Type	Description	Intervention Names
1		all patients treated with Anastrozole	Drug: Anastrozole

Name	Type	Description	Arm Group Labels	Other Names
Anastrozole	Drug		1	Arimidex

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
evaluation of Anastrozole therapy as adjuvant treatment in post.menopausal women with not advanced breast cancer únder naturalistic conditions		12 months

Secondary Outcomes

Measure	Description	Time Frame
description of population treated with anastrozole		12 months
further information about the change of specific laboratory parameters		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Postmenopausal women with early hormone receptor positive breast cancer/no metastasis

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Probability Sample

Name	Affiliation	Role
H Brasch	AstraZeneca Germany	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077384	Anastrozole

Ancestor Terms

ID	Term
D009570	Nitriles
D009930	Organic Chemicals
D014230	Triazoles
D001393	Azoles
D006573

Browse Leaves

Not provided

Browse Branches

Not provided